Screening for TB in Pregnancy. on HIV-Infected Pregnant Women

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Other: Sputum sample

• Registration Number: NCT02520973
• Lead Sponsor: Johns Hopkins University

Brief Summary

Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-09
• Study Start: 2015-05
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-13
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

1. HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA >1000 copies/mL
2. Pregnancy confirmed by urine pregnancy test or clinical exam
3. Estimated gestational age of 13 weeks or older
4. Age 18 years or greater
5. Willing to provide verbal consent

Exclusion Criteria

1. Currently diagnosed with TB
2. Completed TB treatment within the last 6 months
3. Inability to communicate in one of the study languages.
4. Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Universal screening	Sputum sample	All HIV + pregnant women will be asked to give a sputum sample for TB prior to TB symptom screen
Symptom- directed screening	Sputum sample	Only symptomatic HIV+ pregnant women will be asked to give a sputum sample for TB

Primary Outcome Measures

Name	Time	Method
Proportion of women diagnosed with TB	One year	1. Proportion of women who are diagnosed with TB in each arm

Trial Locations

Locations (1)

Perinatal HIV Research Unit; 🇿🇦 Klerksdorp, Northwest, South Africa